European New Texture Implant Clinical Experience With Shaped Breast Implants

Phase 4

Completed

• Conditions: Breast Augmentation
• Interventions: Device: new texture shaped breast implants

• Registration Number: NCT01639755
• Lead Sponsor: Allergan

Brief Summary

The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06-18
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-13
• Primary Completion: 2013-01-30
• Results First Submitted: 2015-07-02
• Results First Submitted QC: 2015-07-02
• Results First Posted: 2015-07-29
• Status Verified: 2017-10
• Study Completion: 2017-10-16
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

• Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or biplanar placement of the breast implants by inframammary approach only
• Be a candidate for the device styles and sizes available in the study

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Exclusion Criteria

• Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome), or grade 3 ptosis
• Have undergone any previous breast surgery
• Have tissue covering determined inadequate or unsuitable by the surgeon

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	new texture shaped breast implants	Al participants who had new texture shaped breast implants surgically implanted.

Primary Outcome Measures

Name	Time	Method
Investigator Overall Satisfaction With the Device Using a 5-Point Scale	3 months	The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire	6 months	Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.
Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue	6 months	The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.
Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale	Interim analysis: 12 months	The investigator evaluated capsular contracture (lining of cells formed around the device as the body's response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.
Percentage of Participants With Local Complications	Interim analysis: 12 months	The percentage of participants experiencing local complications (in the area of the implant) is reported.

Trial Locations

Locations (2)

Klinik 34; 🇸🇪 Göteburg, Sweden

Akademikliniken 10; 🇸🇪 Stockholm, Sweden